Self-Collected Saliva Samples Without Viral Transport Media for COVID-19 Testing Via RT-PCR

Completed · Not applicable

Conditions studied: SARS-CoV Infection, Polymerase Chain Reaction, Laboratory Testing

In brief

This is a study that will attempt to validate the process for detecting SARS-CoV-2 (COVID19) on a non-FDA-approved technology using self-collected saliva as the specimen. Investigators will compare self-collected saliva samples and healthcare-worker collected nasopharyngeal samples (Nasal swabs) to see if the self-collected saliva samples are similar in terms of diagnostic accuracy. Investigators will be performing this testing at the site where patients regularly go for COVID19 testing. There will be minimal risk of harm as consenting patients will only have to provide a small amount of saliva into a tube.

Key facts

Study ID

NCT04604145

Run by

David Grant U.S. Air Force Medical Center

People needed

60

Starts

2021-02-03

Expected to finish

2021-08-18

Last updated by the study team

2021-08-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adult patients who have COVID-19 NP testing at DGMC and are willing to provide a saliva sample within 72 hours
• Adult patients (i.e., inpatient, outpatient) who have positive COVID-19 NP test results at DGMC and are willing to provide a saliva sample within 72 hours of the positive COVID-19 NP test

You may not qualify if…

• Patients unwilling to wait or have eaten, drank or smoked within the past 10 minutes
• Patients unwilling or unable to provide 2 mls of saliva
• For positive control participants only, patients whose most recent positive COVID-19 NP test was collected more than 72 hours ago

Where it is running

• David Grant U.S. Airforce Medical Center — Travis Air Force Base, California, United States

Full record on ClinicalTrials.gov

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